As we progress to value-based healthcare system, it’s more important than ever to keep readmissions to a minimum. A recent study, though, found that more than 17 percent of patients undergoing peripheral revascularization for PVD were readmitted within 30 days of having the procedure.The unplanned readmissions were associated with increased mortality and, not surprisingly, higher costs.

The Research

A team of researchers analyzed records from 61,969 patients in the Nationwide Readmissions Database who met the following criteria:

Were admitted to the hospitali with PAD for patients with

Subsequently treated with peripheral arterial revascularization

Survived to discharge

At the one month mark for each case, unplanned readmission rate was around 17.6 percent. Nearly 30 percent of these unplanned readmissions were attributed to complications related to the procedure. Other common causes include comorbidities such as sepsis (8.3 percent), diabetes complications (7.5 percent) and gangrene (5.1 percent).

The Cost of Hospital Readmission

The cost of readmission was very high, with the median cost totaling $11,013 nationally. According to procedure type, costs were:

$11,567 for endovascular procedures

$10,541 for surgical procedures and

$11,796 for hybrid procedures.

All total, the nationally weighted cost of all readmissions was $401,112,036, according to the report.

Patients at Risk

The study noted that readmission rates were higher in older, women, insured by Medicare or Medicaid, and living in low-income areas and counties amongst larger populations. They also tended to have more comorbidities, including chronic limb ischemia, obesity, hypertension, congestive HF, diabetes and renal disease.

Discharge Planning

Researchers noted that in light of the data, physicians should begin profiling high-risk patients and prioritize discharge planning in order to improve outcomes, and reduce the costs associated with hospital readmission.

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THOUSAND OAKS, Calif., Dec. 1, 2017 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that following priority review of its supplemental Biologics License Application, the U.S. Food and Drug Administration (FDA) approved Repatha® (evolocumab) as the first PCSK9 inhibitor to prevent heart attacks, strokes and coronary revascularizations in adults with established cardiovascular disease.1

“We are pleased that the FDA made the inclusion of our outcomes data a priority so that patients can benefit from Repatha’s ability to reduce life-changing events of heart attacks and strokes,” said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. “Despite treatment with current best therapy, many patients are still at high risk for cardiovascular events. Physicians now have a new FDA-approved treatment option to prevent cardiovascular events by dramatically lowering LDL cholesterol with Repatha, especially for patients already on maximally-tolerated statin therapy who need further LDL cholesterol lowering.”

In the Repatha cardiovascular outcomes study (FOURIER), Repatha reduced the risk of heart attack by 27 percent, the risk of stroke by 21 percent and the risk of coronary revascularization by 22 percent.2

“In the U.S., every 40 seconds someone has a heart attack or stroke, and nearly one in three of these patients will have another event, leading to a societal cost that exceeds $600 billion annually. With this approval, it’s now more important than ever that appropriate patients obtain access to Repatha in order to avoid preventable heart attacks and strokes. We will continue to work with payers to help ensure the patients who need Repatha the most are able to get this innovative medicine,” said Anthony C. Hooper, executive vice president of Global Commercial Operations at Amgen.

The FDA also approved Repatha to be used as an adjunct to diet, alone or in combination with other lipid-lowering therapies, such as statins, for the treatment of adults with primary hyperlipidemia to reduce low density lipoprotein cholesterol (LDL-C).1

Amgen is committed to providing personalized support services for patients and providers in the U.S. through its RepathaReady™ program. RepathaReady is a comprehensive suite of services to help patients and providers, including a Repatha $5 co-pay card for eligible commercial patients, insurance coverage support and injection training. Amgen also provides patient assistance for its medicines marketed in the U.S. in a variety of ways, including free medicines through The Amgen Safety Net Foundation for qualifying individuals with no or limited drug coverage.

The magnitude of risk reduction in both the primary and key secondary composite endpoints grew over time, with the robust benefit starting as early as six months and accruing through the median 2.2 years of the study.

Patients on Repatha experienced a reduction in the risk of heart attack (27 percent, nominal p<0.001), stroke (21 percent, nominal p=0.01) and coronary revascularization (22 percent, nominal p<0.001).2 Consistent with recent trials of more intensive LDL-C lowering, there was no observed effect on cardiovascular mortality. Similarly, there was no observed effect on hospitalization for unstable angina.3-7

The safety profile of Repatha in the outcomes trial was generally consistent with the safety profile for the 12- and 52-week controlled trials involving patients with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HeFH). Common adverse reactions included diabetes mellitus, nasopharyngitis, and upper respiratory tract infection.

Eligible patients with high cholesterol (LDL-C ≥70 mg/dL or non-high-density lipoprotein cholesterol [non-HDL-C] ≥100 mg/dL) and established cardiovascular disease at more than 1,300 study locations around the world were randomized to receive Repatha subcutaneous 140 mg every two weeks or 420 mg monthly plus high- or moderate-intensity effective statin dose; or placebo subcutaneous every two weeks or monthly plus high- to moderate-intensity statin dose. Statin therapy was defined in the protocol as at least atorvastatin 20 mg or equivalent daily with a recommendation for at least atorvastatin 40 mg or equivalent daily where approved. The study was event driven and continued until at least 1,630 patients experienced a key secondary endpoint.

About Repatha® (evolocumab)Repatha® (evolocumab) is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.1

Repatha is approved in more than 50 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union. Applications in other countries are pending.

to reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease.

as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia [HeFH]) to reduce low-density lipoprotein cholesterol (LDL-C).

as an adjunct to diet and other LDL‑lowering therapies (e.g., statins, ezetimibe, LDL apheresis) in patients with homozygous familial hypercholesterolemia (HoFH) who require additional lowering of LDL‑C.

The safety and effectiveness of Repatha have not been established in pediatric patients with HoFH who are younger than 13 years old.

The safety and effectiveness of Repatha have not been established in pediatric patients with primary hyperlipidemia or HeFH.

Important U.S. Safety Information

Contraindication: Repatha is contraindicated in patients with a history of a serious hypersensitivity reaction to Repatha.

Allergic reactions: Hypersensitivity reactions (e.g. rash, urticaria) have been reported in patients treated with Repatha, including some that led to discontinuation of therapy. If signs or symptoms of serious allergic reactions occur, discontinue treatment with Repatha, treat according to the standard of care, and monitor until signs and symptoms resolve.

Adverse reactions: The most common adverse reactions (>5 percent of Repatha-treated patients and occurring more frequently than placebo) in controlled trials involving patients with primary hyperlipidemia, including HeFH, were: nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions.

In a 52-week trial, adverse reactions led to discontinuation of treatment in 2.2 percent of Repatha-treated patients and 1 percent of placebo-treated patients. The most common adverse reaction that led to Repatha treatment discontinuation and occurred at a rate greater than placebo was myalgia (0.3 percent versus 0 percent for Repatha and placebo, respectively).

Adverse reactions from a pool of the 52-week trial and seven 12-week trials: Local injection site reactions occurred in 3.2 percent and 3.0 percent of Repatha-treated and placebo-treated patients, respectively. The most common injection site reactions were erythema, pain, and bruising. The proportions of patients who discontinued treatment due to local injection site reactions in Repatha-treated patients and placebo-treated patients were 0.1 percent and 0 percent, respectively.

About Amgen in the Cardiovascular Therapeutic AreaBuilding on more than three decades of experience in developing biotechnology medicines for patients with serious illnesses, Amgen is dedicated to addressing important scientific questions to advance care and improve the lives of patients with cardiovascular disease, the leading cause of morbidity and mortality worldwide.8 Amgen’s research into cardiovascular disease, and potential treatment options, is part of a growing competency at Amgen that utilizes human genetics to identify and validate certain drug targets. Through its own research and development efforts, as well as partnerships, Amgen is building a robust cardiovascular portfolio consisting of several approved and investigational molecules in an effort to address a number of today’s important unmet patient needs, such as high cholesterol and heart failure.

About AmgenAmgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

Forward-Looking StatementsThis news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen, including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and current reports on Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Discovery or identification of new product candidates or development of new indications for existing products cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate or development of a new indication for an existing product will be successful and become a commercial product. Further, preclinical results do not guarantee safe and effective performance of product candidates in humans. The complexity of the human body cannot be perfectly, or sometimes, even adequately modeled by computer or cell culture systems or animal models. The length of time that it takes for us to complete clinical trials and obtain regulatory approval for product marketing has in the past varied and we expect similar variability in the future. Even when clinical trials are successful, regulatory authorities may question the sufficiency for approval of the trial endpoints we have selected. We develop product candidates internally and through licensing collaborations, partnerships and joint ventures. Product candidates that are derived from relationships may be subject to disputes between the parties or may prove to be not as effective or as safe as we may have believed at the time of entering into such relationship. Also, we or others could identify safety, side effects or manufacturing problems with our products, including our devices, after they are on the market.

Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. If we fail to meet the compliance obligations in the corporate integrity agreement between us and the U.S. government, we could become subject to significant sanctions. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Certain of our distributors, customers and payers have substantial purchasing leverage in their dealings with us. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.

Recent studies have featured the benefits of robotic PCI as a feasible way to treat CAD. But at the annual TCT conference Oct. 30, Ryan D. Madder, MD, presented the idea of “tele-stenting” over long distances. Is it possible for an operator in one part of the country, using robotic technology, to perform a PCI on a patient across the country? What about across the world?

The Current State of Tele-stenting

As the lead investigator of the REMOTE-PCI study, Madder demonstrated that operators can perform PCI while in a separate area from the patient. In the study, the distance was simply across the hall or an adjacent room of a cath lab. But this was only because the robotic technology used in the study required a hardwire connection between the system and the interventional cockpit from which the operator controls the system.

To perform these operations remotely, not just from the next room, the bedside robotic arm would need to be connected to the cockpit control center through a web-based network. The technology does exist, Madder himself pointed to a case from 2001 called “The Lindbergh Operation” wherein an operator in New York performed a robotic laparoscopic cholecystectomy on a patient in France.

“I would argue with all the advances that have been made in internet connectivity, we can probably figure out how to do tele-stenting now,” said Madder, who directed the study on behalf of Corindus Vascular Robotics.

Is Remote Robotic PCI Even Necessary?

The biggest and most important question is: “should we? The PCI was first performed over 40 years ago and has become the most commonly prescribed procedure in interventional cardiology. Aren’t there enough skilled human operators that spending significant money for a second-generation technology like this, is frivolous or wasteful?

While cost is one factor, there are other benefits that must be considered. By removing the interventionalist from the patient’s side, you are also reducing exposure to radiation by up to 97%. Previously, we have discussed that radiation exposure is one deterrent for new physicians entering the profession. There has been great technological success and geographical limitations can also be avoided.

The Next Steps

All of the discussion about remote PCI is sheerly speculative for now, while technology is tested and techniques are perfected. Newer technology is also emerging quickly. Training programs will have to be developed, considering the learning curve for new users of the technology is about three to five cases for simple lesions and 20 to 25 cases for complex lesions. And there are still more device-specific improvements to be made. Regardless, this is a super exciting prospect.

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Globally, about 14 million people are diagnosed with cancer each year. Most patients are treated with chemotherapy, radiation or equally poisonous drugs to combat this ravenous disease. Many times, these treatments cause awful side affects and inflict the patient with even more maladies. However, a new range of targeted molecular therapies may, eventually, be able to help millions of patients without harming the patient’s body more than the cancer already has.

How it works

According to My Cancer Genome, with molecular therapy “therapeutic monoclonal antibodies target specific antigens found on the [cancerous] cell[‘s] surface.” This therapy acts on a molecular level to destroy cancer cells without destroying other healthy cells that would be affected by most other treatments. A pathologist works closely with the patient, to determine what their molecular targets are going to be. Unfortunately, all cancers are different so molecular therapy is not a feasible option for everyone or all types of cancer. However, this treatment has the potential to help millions maintain a higher quality of life while undergoing cancer treatment.

Types of cancers molecular therapies are effective on

While molecular therapy may not work in all cases, researchers at Penn Medicine have found that it can be effective in these types of cancers: brain cancer, breast cancer, GI cancer, kidney cancer, leukemia, lung cancer, melanoma, prostate cancer and thyroid cancer.

Molecular therapy limitations

The National Cancer Institute has identified several curbs in molecular therapy treatments. Cancer cells may become immune to the therapies through mutation or new pathways. Therefore, it is sometimes beneficial to use molecular therapies in combination. Additionally, sometimes it may be exceedingly difficult to identify a target for the therapy. What may work for one case of breast or brain cancer, may not work for another.

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Today’s workforce is often full of diversity, including generational gaps commonly spanning over decades. It isn’t unusual to have four different generations of employees working together. This can be a plus on many levels, since each generation brings their own unique strengths and knowledge to the workplace.

If managed improperly, these differences may also lead to conflict and miscommunication. In order for a business to succeed, managers need to ensure a united enviroment. Traditional management methods might not be practical for all generations. There are widespread principles that are common characteristics for each age demographic.

Given these specific differences, organizations should be devoted to assisting these unmistakably different groups of people in order to work together cohesively and stay inspired.

Finding the right motivation for each group is essential. More seasoned employees may value financial incentives, while fledgling employees may opt for time off. Allowing workers to choose what they would prefer can help to avoid any potential discord.

Every workplace should be thought of as a place to improve minds. Implementing a mentoring program will allow older employees the opportunity to share their wisdom and knowledge, while the younger generation teaches them about technology.

Instead of using a generalized performance evaluation, businesses should consider using a more individualized approach. Some generations may be more capable in certain areas, while the other half struggles. Doing this ensures that your company is boosting their employees strengthens, while minimising weaknesses.

With such a growing number of cross generations in the workforce, companies have the good fortune to fully integrate today’s generation with previous era’s work ethics. The result can be a truly close-knit environment to thrive in for all concerned.

Our strategy focuses on enabling our clients to identify, attract and retain the right people for the structure in which they will perform. Please contact us to learn more about our expertise in Executive Search for Leadership positions in Medical Device and Biotechnology. We look forward to the opportunity to help you consistently improve your performance and your business!

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